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  • Audits (internal & vendor)

  • 21 CFR part 11

  • CAPA

  • CRO/CMO oversight

  • Change Control

  • Deviations

  • Disaster Recovery

  • Documentation

  • Quality Manual

  • Training

  • Validation (CSV, GAMP 5, Method, Process)

FDA inspections are typically unannounced.


You MUST grant them access during normal business hours.


Are you ready for the FDA tomorrow morning?

Oversight Plans



  • Clinical

  • CMO

  • Outsourced services


Critical as the sponsor when you have outsourced functions.


Can you prove you are meeting your

Sponsor obligations?



QC Services



  • Environmental Monitoring

  • Final Release

  • Receipt Inspection

  • Method Development /Qualification 

  • Out of Specification (OOS)

  • Scale-up & Tech Transfer

IT Configurations



  • Front end and back end

  • Network security

  • Infrastructure qualification

  • GXP computerized systems

  • Lifecycle

  • VPN for employee remote access


IT stability increases uptime, allowing employees greater flexibility in performing their duties. 


The results are increased job satisfaction!

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